Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.
研究概览
简要总结
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results.
The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.
详细描述
182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum.
Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •LSC simple hysterectomy,
- •Neg. SS test if premenopausal
- •Consent to participate in the study
- •Understanding of the German language
排除标准
- •Prolapse as indication for surgery
- •Known or suspected non-compliance
- •Additional incontinence procedures
- •Patients with deep infiltrating endometriosis
- •Irradiation pre- or postoperative
- •Pregnancy and lactation.
- •Conversion from laparoscopy to laparotomy
- •Inability to understand the study protocol
研究组 & 干预措施
standard cuff closure
Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)
干预措施: Standard cuff closure (Procedure)
McCall suture
Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.
干预措施: McCall suture (Procedure)
结局指标
主要结局
Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.
时间窗: 5 years
Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years. Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen.
次要结局
- Sexual function(5 years)